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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceenVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS040
Date Received12/20/2019
Decision Date01/16/2020
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Alternate milling process and an optional cleaning/drying step prior to batch milling for the enVista Hydrophobic Acrylic Intraocular Lenses, Models MX60, MX60E, MX60T, MX60ET and MX60PL.
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